Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety and Toxicity
研究概览
简要总结
RATIONALE: Vaccines made from gene-modified cancer cells may help the body build an effective immune response to kill cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with imatinib mesylate may be an effective treatment for chronic myelogenous leukemia.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of GM-K562 cell vaccine when administered with imatinib mesylate in patients with persistent chronic phase chronic myelogenous leukemia in first hematologic response.
- Determine the safety and toxic effects of GM-K562 cell vaccination in these patients.
Secondary
- Determine the disease response by serial BCR-ABL quantitative polymerase chain reaction measurements in patients treated with this regimen.
- Determine the development of tumor immunity in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of chronic myelogenous leukemia
- •Chronic phase disease
- •Philadelphia chromosome positive disease
- •Disease in first complete hematologic response, defined by all of the following:
- •Complete normalization of peripheral blood counts with WBC < 10,000/mm^3
- •Platelet count < 450,000/mm^3
- •No immature cells (e.g., myelocytes, metamyelocytes, or blasts) in the peripheral blood
- •Persistent molecular evidence of disease
- •Detectable BCR-ABL transcript by quantitative polymerase chain reaction
- •Less than 2 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared to a standardized baseline
- •Must have received imatinib mesylate for > 1 year of which the last 3 months were at stable dose ≥ 300 mg/day
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Negative pregnancy test
- •No known HIV
- •ALT or AST ≤ 3 times upper limit of normal
- •Oxygen saturation ≥ 93% at room air
- •No history of recent acute myocardial infarction
- •No history of unstable angina
- •No pulmonary decomposition requiring hospitalization within the past 3 months
- •No concurrent and/or uncontrolled psychiatric or medical condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior allogeneic stem cell transplantation
- •At least 2 months since other prior experimental therapy
- •At least 6 months since prior participation in another vaccine study
- •No concurrent systemic immunosuppressive medication
排除标准
- 未提供
结局指标
主要结局
Safety and Toxicity
时间窗: 3 years
To assess the safety and toxicity of GM-K462 vaccination in CP CML patients who have acheived a complete hematologic response to imatinib.
次要结局
- Disease Response(3 years)
- Tumor immunity(3 years)
研究者
Martha Wadleigh, M.D.
Principal Investigator
Dana-Farber Cancer Institute